Advanced Technology for Vector-Based Therapies Highlighting Stem Cell-Derived Exosomes Manufacturing Process

This webcast features: Elie Zakhem, PhD, PMP, Senior Manager, Process Development, RoosterBio Inc., Lauren Torres, Field Applications Scientist, Repligen, Jeremy Neidert, Bioprocessing Account Manager, Repligen.

The number of clinical trials investigating viral vectors and MSC-EVs as therapeutic and skincare agents has been increasing greatly over the years. The complexity and fragility of the vector-based products, scalability, yield, and purity of production processes are challenges to meeting demand. With this comes the requirement to ensure that there are robust manufacturing processes in place to scale with demand and to make these therapies readily accessible to those who need them.

However, current manufacturing processes for vectors and exosomes have often been developed with limited scalability in mind and large shifts in technology must take place to enable industrialization. To overcome this challenge, we are presenting industrialization of an MSC-EVs case study which illustrates the next generation manufacturing process for large volume upstream manufacturing using high-quality hMSCs along with paired bioprocess medium formulations for cell growth and EV production and downstream clarification using tangential flow depth filtration (TFDF) system and highly efficient exosome concentration using tangential flow filtration (TFF) with hollow fibers. Parameters identified during the development phase of this study can be scalable to 2000 L bioreactor. For this case study, we will show the benefits of integrated manufacturing platforms for high-productivity and cost-effective exosome manufacturing to meet the increasing global demand.

Key Takeaways:

  • Understanding industrial solutions for manufacturing of functional hMSC exosomes using scalable and low shear technologies that enable cost-effective commercialization of these advanced therapies.
  • Learning how high recovery yields of potent EV was achieved at small-scale and large-scale cGMP compatible production.
  • Analyzing how the EV downstream clarification and concentration process steps using the KrosFlo® TDFD® and KR2i with hollow fibers demonstrated high recovery and simplified the downstream process.
  • Demonstrating the impact of integrated automated single-use high flux platforms on process time at scale of fully functional exosomes.

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